Zenovel Pharma Services LLP

Adverse Event Assessment

In BA-BE research, many a time investigators use subjective language to describe the symptoms of an Adverse event or a Side Effect. Frequent use of subjective judgement in the AE severity assessment as well as in the AE reporting is commonly observed.

Individual assessment is unlikely to help determine attribution for common AEs.

The assessment of an adverse event and its severity should be based on an Investigator’s clinical judgement and such Clinical Judgement should be based on standardized and consistent classifications.

Proper scientific terminology should be used to assess and report AEs.

The Common Terminology Criteria for Adverse Events (CTCAE) is one of the tools that offer a standardized language to report adverse events by assigning uniform terminology for symptoms and a grading system to assess AE severity.

CTCAE gives a set of terminology which can easily be understood. CTCAE is also useful to grade symptoms or adverse events which in a way makes it possible to quantify symptoms and analyze improvement or deterioration of symptoms.

Quantifying information not only helps in the determination of the efficacy and toxicities related to specific treatments but also in the comparison of safety profiles across different interventions and different studies.

Uniform reporting of AEs, also promotes consistency within a given grade across all AEs.

At Zenovel we are highly concerned about the safety of trial participants.